Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-07 @ 12:58 AM
Study NCT ID:
NCT04870892
Status:
UNKNOWN
Last Update Posted:
2021-05-04
First Post:
2021-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2021-04-23', 'studyFirstSubmitQcDate': '2021-04-28', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference of capillary refill time before and after the therapeutic change', 'timeFrame': 'Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose', 'description': "Capillary refill time is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera."}], 'secondaryOutcomes': [{'measure': 'Correlation between capillary refill time and perfusion index', 'timeFrame': 'Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose', 'description': "Capillary refill time is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera."}, {'measure': 'Least significant change of capillary refill time', 'timeFrame': 'Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose', 'description': "Capillary refill time is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera."}, {'measure': 'Difference between capillary refill time on thorax and on the index finger tip', 'timeFrame': 'Change from capillary refill time between the 15 min before the therapeutic, Immediately after fluid administration and within the 15 minutes of a change in norepinephrine dose', 'description': "Capillary refill time is time required for return of color after application of blanching pressure to a distal capillary bed. In this study, we made a calibrated compression of the skin using a piston for seven seconds, and we recorded CRT with a smartphone's video camera."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['septic shock', 'capillary refill time', 'norepinephrine', 'fluid infusion'], 'conditions': ['Septic Shock']}, 'referencesModule': {'references': [{'pmid': '37932812', 'type': 'DERIVED', 'citation': 'Fage N, Moretto F, Rosalba D, Shi R, Lai C, Teboul JL, Monnet X. Effect on capillary refill time of volume expansion and increase of the norepinephrine dose in patients with septic shock. Crit Care. 2023 Nov 6;27(1):429. doi: 10.1186/s13054-023-04714-0.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.', 'detailedDescription': 'An interventional study compared, in septic shock, the effect of resuscitation strategy targeting normalization of capillary refill time versus strategy targeting serum lactate level. This last highlight a decrease of organ dysfunction at 72 hours with capillary refill time strategy and non-significant trend towards lower 28-day mortality in the capillary refill time strategy group.\n\nThe strategy guided by the decreasing of capillary refill time allowed the administration of less fluid than that guided by lactate. This is an important advantage when the intensive care doctor know that the mortality of patient in septic shock increases with the amount of fluid administered.\n\nHowever, the variations of capillary refill time induced by the principal treatment in septic shock (norepinephrine and fluid resuscitation) during circulatory failure are actually insufficiently described. The purpose of this study is to assess the effect of norepinephrine and fluid expansion on capillary refill time during septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with septic shock, cardiac output monitoring device with the PICCO2 system', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Septic shock\n* Presence of a cardiac output monitoring device with the PICCO2 system (Pulsion Medical Systems, Feldkirchen, Germany)\n* Decision by the physician in charge to perform vascular filling or modification the norepinephrine dose\n\nExclusion Criteria:\n\n* Pregnant\n* Patient under a tutelage measure or placed under judicial protection'}, 'identificationModule': {'nctId': 'NCT04870892', 'acronym': 'NOVECAR', 'briefTitle': 'Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Bicetre Hospital'}, 'officialTitle': 'Effects of Norepinephrine and Volume Expansion in Capillary Refill Time in Septic Shock', 'orgStudyIdInfo': {'id': '2021-A00624-37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Norepinephrine variation', 'description': 'Patients with septic shock, cardiac output monitoring device with the PICCO2 system and decision by the physician in charge to modify the norepinephrine dose.'}, {'label': 'Fluid infusion', 'description': 'Patients with septic shock, cardiac output monitoring device with the PICCO2 system and decision by the physician in charge to give fluid infusion'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier Monnet, MD, PhD', 'role': 'CONTACT'}, {'name': 'Xavier Monnet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Intensive Care Unit', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'centralContacts': [{'name': 'Xavier Monnet, MD-PhD', 'role': 'CONTACT', 'email': 'xavier.monnet@aphp.fr', 'phone': '+33-(0)6660862669'}, {'name': 'Nicolas Fage, MSC', 'role': 'CONTACT', 'email': 'fage.nicolas@gmail.com'}], 'overallOfficials': [{'name': 'Xavier Monnet, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Médecine Intensive - Réanimation, Hôpital Bicêtre, AP-HP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bicetre Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xavier Monnet', 'investigatorAffiliation': 'Bicetre Hospital'}}}}